Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans

NCT04685850 | Terminated

• 1 other identifier: SEINE
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 9

Brief Summary

While the initial evolution of meningococcal meningitis (MM) is well described, there are few data on the long-term evolution, beyond 1 year. The objective of this research is to evaluate the sequelae of MM beyond 1 year in patients with a history of MM followed in Paris area, France. Most children with MM in France have been included in the MM register and are still being followed. Parents will be offered a detailed clinical evaluation of their child including: a clinical and neurological examination, a cognitive performance assessment, an auditory, speech and visual assessment and an evaluation of the child's progress at school.

Conditions

Meningitis, Meningococcal; Sequela

Outcome Measures

Primary Outcomes (1)

• Number of children with at least one neurological, orthopedic or sensory sequelae

  1 year

Secondary Outcomes (8)

• Number of children with severe neurological sequelae

  1 year

• Number of children with orthopedic complications

  1 year

• Number of children with sensory disorders

  1 year

• Number of children with skin sequelae

  1 year

• Number of children with learning disabilities

  1 year

Interventions

sequela evaluation OTHER

clinical and neurological examination, psychological evaluation (cognitive performance), an auditory, speech and visual assessment and an evaluation of the child's school performance

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children from 0 to 17 years old who had meningococcal meningitis between 2010 and 2019

You may qualify if:

• Infants and children from 0 to 17 years old
• Having had meningitis or meningococcal purpura fulminans between 2010 and 2021
• The holders of parental authority have read and understood the information letter and their express consent has been obtained
• Patient affiliated to a social security system (Social Security or Universal Medical Coverage)

You may not qualify if:

• refusal to participate

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead
• Association Clinique Thérapeutique Infantile du val de Marne: collaborator

Study Sites (9)

CHU Bicêtre

Le Kremlin-Bicêtre, Kremlin Bicêtre, 94720, France

Location

CHU Annecy

Annecy, 74370, France

Location

CHI créteil

Créteil, 94000, France

Location

Centre Intercommunal de Villeneuve Saint Georges

Crosne, 91560, France

Location

Groupe Hospitalier Nord Essonne

Longjumeau, 91345, France

Location

GHEF site de Meaux

Meaux, 77100, France

Location

Hôpital Necker Enfants Malades

Paris, 75015, France

Location

Robert debré hospital

Paris, 75019, France

Location

Ch Pontoise

Pontoise, 95300, France

Location

Related Publications (1)

• Baloche A, Jung C, Levy M, Elbez-Rubinstein A, Bechet S, Layouni I, Monguillot G, Taha MK, Cohen R, Levy C. Long-term impact of invasive meningococcal disease in children: SEINE study protocol. PLoS One. 2022 May 26;17(5):e0268536. doi: 10.1371/journal.pone.0268536. eCollection 2022.

  PMID: 35617288 DERIVED

Related Links

• Long-term impact of invasive meningococcal disease in children: SEINE study protocol

MeSH Terms

Conditions

Meningitis, Meningococcal

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: July 9, 2021
• Primary Completion: May 19, 2025
• Study Completion: May 19, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)